In an article published this month in Clinical Trials, researchers from the NIH Pragmatic Trials Collaboratory’s Distributed Research Network share opportunities for conducting pragmatic trials embedded in health insurance plans.

“There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensings, vaccine administrations, behavioral healthcare encounters, and some laboratory results.”

These types of trials can be used to assess whether an intervention is effective in different geographical locations, populations, and multiple complex organizations, and are best suited to studies that require large sample sizes. Health insurance data can be used to identify eligible individuals, facilitate patient and provider contact, and/or analyze the study outcomes.

Although trials embedded in health insurance plans hold the potential to generate evidence to improve care and population health, there are special challenges that must be considered in the planning, implementation, and analytic phases. Important logistical challenges require careful planning, including planning for timing (plan enrollment and disenrollment is typically at the beginning and end of a calendar year), lag time for data availability, and engagement of staff from health plans and providers. The intervention itself must also be fairly simple, as interventions will be disseminated through health plans.

For more, see the Distributed Research Network page on the Living Textbook or read the full article.